Proposed Requirements for ANDA Holders under 314.70(c)(8) and 314.70(c)(8)(ii)

Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Proposed Rule

Documents and Forms

Document Name Document Type

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

IC Title:	Proposed Requirements for ANDA Holders under 314.70(c)(8) and 314.70(c)(8)(ii)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 314.70(c)(6)(iii)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 15	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 75 %

	Requested	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	20	20
Annual IC Time Burden (Hours)	300	300
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.